Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-04-25 @ 7:31 AM
Study NCT ID:
NCT03142503
Status:
COMPLETED
Last Update Posted:
2017-05-05
First Post:
2017-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The DIET Trial - Dietetic Intervention in Psoriatic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D025241', 'term': 'Spondylarthritis'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2017-04-06', 'studyFirstSubmitQcDate': '2017-05-04', 'lastUpdatePostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease activity', 'timeFrame': '12 weeks', 'description': 'To evaluate the increase of Minimal Disease Activity (MDA) after intervention'}], 'secondaryOutcomes': [{'measure': 'Fat Mass', 'timeFrame': '12 weeks', 'description': 'To analyze the decrease of Fat Mass Index (kg/m\\^2)'}, {'measure': 'Lean Mass', 'timeFrame': '12 weeks', 'description': 'To evaluate the increase of Muscle Mass (kg)'}, {'measure': 'Waist circumference', 'timeFrame': '12 weeks', 'description': 'To observe the improvement of waist circumference (cm)'}, {'measure': 'Body Mass Index', 'timeFrame': '12 weeks', 'description': 'To analyze the improvement of Body Mass Index (kg/m\\^2)'}, {'measure': 'Glycation markers', 'timeFrame': '12 weeks', 'description': 'To analyze the decrease of receptor for advanced glycation end products receptor (RAGE)'}, {'measure': 'Anti-inflammatory marker', 'timeFrame': '12 weeks', 'description': 'To analyze the increase of adiponectin'}, {'measure': 'Lipidic Peroxidation', 'timeFrame': '12 weeks', 'description': 'To analyze the improvement of malondialdehyde (TBARs)'}, {'measure': 'Inflammatory markers', 'timeFrame': '12 weeks', 'description': 'To observe the improvement of LDL fractions'}, {'measure': 'Cutaneous activity', 'timeFrame': '12 weeks', 'description': 'To evaluated the reduction in cutaneous activity, evaluated by PASI (Psoriasis Area Severity Index)'}, {'measure': 'Articular activity', 'timeFrame': '12 weeks', 'description': 'To evaluate the decrease of articular activity, evaluated by DAS28-CRP (Disease Activity Score-C reactive protein) and DAS28-ESR (Disease Activity Score-Erythrocyte Sedimentation Rate).'}]}, 'conditionsModule': {'keywords': ['psoriatic arthritis', 'psoriasis', 'body composition', 'DXA measurements', 'spondyloarthritis', 'diet therapy', 'adipose tissue'], 'conditions': ['Arthritis, Psoriatic', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '38872193', 'type': 'DERIVED', 'citation': 'Scherer D, Leite BF, Morimoto MA, Oliveira TL, Klemz BNC, Freitas RAMS, Pappiani C, Damasceno NRT, Pinheiro MM. Nutritional effect on lipoproteins and their subfractions in patients with Psoriatic Arthritis: a 12-week randomized trial-the DIETA trial. Adv Rheumatol. 2024 Jun 13;64(1):47. doi: 10.1186/s42358-024-00389-5.'}, {'pmid': '35387686', 'type': 'DERIVED', 'citation': 'Leite BF, Morimoto MA, Gomes CMF, Klemz BNC, Genaro PS, Shivappa N, Hebert JR, Damasceno NRT, Pinheiro MM. Dietetic intervention in psoriatic arthritis: the DIETA trial. Adv Rheumatol. 2022 Apr 6;62(1):12. doi: 10.1186/s42358-022-00243-6.'}]}, 'descriptionModule': {'briefSummary': 'Psoriasis (Ps) and psoriatic arthritis (PsA) are associated with increased risk of metabolic syndrome (MetS), body fatness and cardiovascular risk. Additionally, oxidative stress and inflammation are also contributing mechanisms on Ps and PsA. However, little is known about the influence of diet and micronutrients on the main outcomes of these diseases. The aim of the investigators is to evaluate the effectiveness of an intervention diet program on disease activity, metabolic profile and oxidative stress inpatients with Psoriasis and Psoriatic Arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with psoriatic arthritis, according to the Classification Criteria of Psoriatic Arthritis (CASPAR)\n\nExclusion Criteria:\n\n* lack of written informed consent;\n* age \\< 18 years old;\n* history of gastrointestinal, endocrine, pulmonary, kidney, hepatic, and neuromuscular diseases, as well as HIV-positive;\n* pregnant or breast-feeding women;\n* previous history of cancer;\n* use of steroids, protein supplements, vitamins, multivitamins, or antioxidants.\n* Specific medications to PsA and physical activity were required to be stable for the last 3 months to be included in the study'}, 'identificationModule': {'nctId': 'NCT03142503', 'acronym': 'DIET', 'briefTitle': 'The DIET Trial - Dietetic Intervention in Psoriatic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Effectiveness of a Dietary Intervention Program on Disease Activity, Metabolism and Oxidative Stress in Patients With Psoriatic Arthritis and Psoriasis Activity: A Clinical, Randomized, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '2012/18701-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Soybean supplementation', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diet + placebo', 'description': 'Soybean supplementation and diet intervention', 'interventionNames': ['Dietary Supplement: Diet + placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Diet + Supplementation', 'description': 'Omega 3 and diet intervention', 'interventionNames': ['Dietary Supplement: Diet + supplementation']}], 'interventions': [{'name': 'Diet + supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Supplementation of 1g of fish oil, 3 time a day, and hypocaloric diet (-500 calories) for 12 weeks, to evaluate weight loss, antioxidant markers and disease activity.', 'armGroupLabels': ['Diet + Supplementation']}, {'name': 'Diet + placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Supplementation of 1g of soybean oil, 3 times a day, and hypocaloric diet (-500 calories) for 12 weeks, to evaluate weight loss, antioxidant markers and disease activity.', 'armGroupLabels': ['Diet + placebo']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Supplementation of 1g soybean oil, 3 times a day.', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Marcelo M Pinheiro', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}